Class IIOngoing

HADLIMA (adalimumab-bwwd) injection recall

FDA recall D-0099-2026 · initiated Oct 10, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility.

Details

Product: HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Recalling company: Samsung Bioepis Co Ltd
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed only to one warehouse in NJ. with no further distribution
Initiated: Oct 10, 2025
FDA report date: Nov 5, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0099-2026 ↗

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